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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K041273
Device Name ONE-STEP PREGNANCY TEST
Original Applicant
W.H.P.M., INC.
163 cabot st.
beverly,  MA  01915
Original Contact fran white
Regulation Number862.1155
Classification Product Code
LCX  
Date Received05/12/2004
Decision Date 05/20/2004
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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